RU2733971C1 - Catheter pump comprising drive unit, and catheter - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention relates to medical equipment, namely to a catheter pump used as a system of temporary circulatory support in an arterial vascular bed, for example in patient's aorta, in particular, when natural heart is unable to provide body with sufficient oxygenated blood. Catheter pump having a catheter having a pump head provided at the distal end of the catheter for insertion into the arterial vascular system, comprises an external catheter and an internal catheter disposed in an external catheter having a rotor shaft arranged to rotate in the internal catheter to actuate the expandable transfer member provided on the pump head, having an actuating portion provided on the proximal end of the catheter, by which the rotor shaft can be actuated, and has a cell surrounding the transfer member. Cage has distal and proximal clutches and filaments passing between the clutches. Proximal coupling is configured to move axially towards the distal coupling in order to expand the cell. Actuating part comprises a part of the base, which is coupled in movement with the internal catheter in the axial direction, and an actuating part, which can be moved relative to the base part in the axial direction and directed to the base part. Proximal end of the external catheter having the actuator portion and the distal end of the external catheter having the proximal coupling is conjugated in axial motion so that when the actuator moves from the base portion, the proximal coupling moves to the distal coupling, wherein said actuator comprises inlet for sprinkling fluid to be transferred to bearing element bearing points. At that, said part has outlet for sprinkling fluid coming from bearing points.

EFFECT: purpose of the present invention consists in providing a catheter pump of the type described at the beginning, by means of which the cell can be expanded functionally reliably.

11 cl, 3 dwg

Description

The invention relates to a catheter pump having a catheter having a pump head provided at the distal end of the catheter for introduction into the arterial vascular system, in particular into the aorta or heart, the catheter comprises an external catheter and an internal catheter located in an external catheter that has a shaft a rotor, pivotally arranged in an inner catheter, for driving an expandable transfer member provided on the pump head, which has an actuator provided at the proximal end of the catheter by means of which the rotor shaft can be driven and which has a cage surrounding the transfer member, a cage has a distal and proximal sleeve and filaments passing between the sleeves, the proximal sleeve can be moved to expand the cage axially towards the distal sleeve. In this process, the regions of filaments lying between the sleeves are expanded radially outward in order to form a chamber surrounding the expanding transfer member.

Such catheter pumps are known, for example, from EP 2 288 392 A1 (US 2011/282128). As described in EP 2 288 392 A1, for example, a rotor having propellers that can be expanded can be used as a rotating transfer element, this rotor is provided at the distal end of the catheter. It is also conceivable that transferring elements of a different geometric shape can be used, for example, a spiral of a spiral shape.

Catheter pumps are used as a temporary circulatory support system in the arterial vascular bed, for example, in the aorta of patients, in particular when the natural heart is unable to provide the body with sufficient oxygenated blood. The transfer element and rotor shaft operate at relatively high speeds in the 7000 to 15000 rpm range. The pump head of the catheter pump can remain in the patient for several days.

It is an object of the present invention to provide a catheter pump of the type described at the outset with which a cell can be expanded in a functionally reliable manner.

This object is achieved by means of a catheter pump having the features of claim 1. In accordance with the invention, the actuator portion thus has a base portion that is axially coupled with the inner catheter in motion and an actuator portion that can be moved relative to the base portion. in the axial direction and directed to or towards a part of the base, the proximal end of the outer catheter is mated in motion with the actuator and the distal end of the outer catheter is mated in motion with the proximal sleeve in the axial direction so that when the actuator is moved away from the part of the base, the proximal sleeve is moved to distal sleeve.

Since the actuator is designed to be guided onto or into the base part, a reliable relative movement can be provided between the base part and the actuator. However, since the proximal end of the outer catheter is mated in motion with the actuator and the distal end of the outer catheter is mated in motion with the proximal sleeve in the axial direction, actuation of the actuator with respect to the base portion means that the proximal sleeve is moved distally towards the distal sleeve, and so on. the filaments of the cell expand radially outward to provide a chamber surrounding the transfer member. The base part is preferably arranged so that it is proximal to the actuator, i.e. the actuator is positioned between the base part and the pump head. When the actuator is moved towards the base part, it is preferable not only to expand the cage, but also simultaneously or shortly thereafter, the transfer element is actuated from its contracted or folded position to the expanded position.

For sufficient lubrication and irrigation of the bearing points of the transfer member, the actuating part has an inlet for the irrigation fluid and the base part has an outlet for the irrigation fluid coming from the carrier points. In this regard, the irrigation fluid can be pumped into the catheter and directed to the carrier points through the actuator or its inlet. At least a portion of the infused irrigation fluid may be removed from the catheter through a portion of the base or its outlet.

Advantageously, if the actuator has an inlet chamber connected to the inlet, the inner catheter passes through the inlet chamber, and the inlet chamber is connected to an inlet lumen provided between the outer catheter and the inner catheter, so that irrigation fluid passing through the inlet can flow through the inlet. a chamber and an inlet lumen to the bearing points of the transfer element. As a result, the irrigation fluid does not come into contact with the shaft rotating in the inner catheter. In this way, contamination of the irrigation fluid can be prevented. An inner catheter, which has a rotor shaft rotating therein during operation, can nevertheless be safely guided through the inlet chamber to a portion of the base.

In order to still allow relative movement between the actuator and the base part, it is advantageous if the inlet chamber on the proximal side is bounded by a piston part of the base part, this piston part can be axially displaced into the inlet chamber. This portion of the piston favorably receives the proximal end of the inner catheter through which the rotor shaft extends to the proximal end of the base portion. The provision of a piston portion means that the irrigation fluid cannot flow proximally from the actuator portion; however, the actuating part can be moved relative to the base part in the axial direction. Preferably, the piston portion comprises, on its radial outer side, a peripheral seal ring which allows axial displacement and also ensures the tightness of the intake chamber. The inlet chamber advantageously has the smallest possible volume in order to change the volume of the inlet chamber as little as possible when the actuator is actuated.

It is also advantageous if the base portion comprises a sleeve-like carrier portion having a receiving chamber, where carrier points are provided to pivotally mount the proximal end of the rotor shaft. The base part is thus at its distal part a piston part and in the proximal direction a bearing part attached thereto. The rotor shaft runs axially through the receiving chamber. The rotor shaft can essentially be formed in one piece or in several pieces. In order to achieve efficient placement of the proximal end of the rotor shaft, it is advantageous if said shaft is rigid in the receiving chamber. However, in a catheter, the rotor shaft can be designed to be flexible so that the catheter, along with the rotor shaft, has a certain amount of flexibility. The bearing sleeve can be provided in a receiving chamber in which the bearing points of the bearing sleeve are fixed in the form of pivot bearing rings, in particular in the form of bearing rings with sliding rollers. Two mutually axially spaced bearing points are preferably provided to ensure a secure positioning of the proximal end of the rotor shaft, in particular in the axial and radial direction. In order to remove the irrigation fluid and to lubricate the rotor shaft rotating in the inner catheter, it is advantageous if the receiving chamber is connected to an outlet lumen provided between the inner catheter and the rotor shaft so that the irrigating fluid passing through the outlet lumen can flow through the receiving chamber. camera for release.

The arrangement is such that the irrigation fluid, which flows from the outlet lumen into the receiving chamber, flows through the bearing points that position the proximal end of the rotor shaft for cooling, irrigation and lubrication. The rotary carrier can have cutouts, for example in the form of axially extending holes, through which the irrigation fluid can be guided.

The base part also favorably provided at its proximal end with an outlet chamber connected to the outlet, the irrigation fluid flowing from the receiving chamber, flowing through the outlet chamber into the outlet after it has flowed favorably through the bearing points.

The proximal free end of the rotor shaft preferably provides a rotatable mating portion provided in the outlet chamber. The rotary mating part can be rotatably contactlessly coupled with the drive by means of magnetic elements.

For an additional reliable mutual direction of the actuator and the base part, it is advantageous if the actuator has at its proximal end a cylindrical sliding receptacle for a piston-like sliding part from the base part. As a result, reliable axial actuation of the actuator and the base portion can be achieved without the portions capable of flexing when moving towards each other.

The sliding part is advantageously formed in the parts with the outer part of the carrier part.

Additional advantages and advantageous embodiments of the invention can be found in the following description, on the basis of which an embodiment of the invention has been described and explained in more detail.

In the figures:

in fig. 1 shows a catheter pump containing a drive unit and a catheter;

in fig. 2 is a longitudinal section through the actuating part of the catheter pump in accordance with FIG. 1 in a non-actuation position for the pump head; and

in fig. 3 shows the actuator in accordance with FIG. 1 in the activated working position.

FIG. 1 shows a catheter pump 10 and a drive unit 12 for driving a catheter pump 10. The catheter pump 10 has a catheter 14 and, at its distal end, a pump head 16 for insertion, in particular into the aorta or heart. A rotor shaft is provided in the catheter 14, by means of which a transfer element 18, for example a rotor with foldable propellers provided in the pump head 16, can be driven into rotation. The transfer member 18 is surrounded by a cage 20 which has a distal sleeve 22 and a proximal sleeve 24, as well as filaments 26 extending between the sleeves. In order to expand the cage 20 and also the transfer member 18, the proximal sleeve 24 is moved axially towards the distal sleeve.

At its proximal end, an actuation part 28 is provided in the catheter 14, by means of which the distal sleeve can be moved to the proximal sleeve 24. In addition, the actuation part 28 can be inserted into the drive unit 12, by means of which the rotor shaft can finally be driven and thus transfer element 18.

The sections in accordance with FIG. Figures 2 and 3 show an actuator 28 which comprises a base portion 30 and an actuator 32 that can be moved relative to the base portion 30 in the axial direction. It is also clear that catheter 14 has an outer catheter 34 and an inner catheter 36 that can be axially displaced in the outer catheter 34. A rotary rotor shaft 38 is provided in the inner catheter 36.

In order to unfold the cage 20 or the transfer member 18, the actuating part 32 is thus moved distally from the base part 30, starting from the basic state shown in FIG. 2 until it finally assumes the driving state shown in FIG. 3, where the cage 20 or its filaments 26 are unfolded. In this actuation state, the actuator 28 is positioned in the drive unit 12 shown in FIG. 1. The rotor shaft can then be driven so as to drive the transfer member 18 by a drive motor provided therein, as described below.

The outer catheter 34 is arranged at its proximal end 40 so as to be fixed to the actuator portion 32. The inner catheter 36 engages in the actuating portion 32 in the axial direction and its proximal end 58 is arranged to fix it to the base portion 30 ...

By axial actuation of the actuator 32 relative to the base portion 30, the outer catheter 34 can thus be moved relative to the inner catheter 36. Since the distal sleeve 24 of the cell 20 mates in motion with the inner catheter 36 and the proximal sleeve 22 mates in motion with the outer catheter in the axial direction, the relative movement of the actuator 32 relative to the base portion 30, and thus the outer catheter 34 relative to the inner catheter 36, can move the proximal sleeve 22 towards the distal sleeve 24 or away from the distal sleeve 24 in order to expand the cage 20 or compress or collapse the cage 20. The mating in motion is such that not only the cage 20, but also the transfer member 18 is expanded distally, either simultaneously with the cage 20, or preferably shortly thereafter, when the actuator 32 is moved.

As is clear from FIG. 1 and 2, the actuator portion 32 has an inlet 44 in which a hose 46 is disposed, through which the irrigation fluid can be pumped to the bearing points of the transfer member 18. Accordingly, in the base portion 30 there is an outlet 48 where the outlet there is a hose 50, through which it is possible to remove the irrigation fluid coming from the bearing points of the transfer element 18.

During operation, the scrubbing fluid as shown in FIG. 3, thus flows through the hose 46 into the inlet 44. An inlet chamber 52 connected to the inlet 44 is provided in the actuator portion 32 and is connected to an inlet lumen provided between the outer catheter 34 and the inner catheter 36. As a result, the irrigation fluid can flow from the inlet chamber 52 through the inlet lumen to the bearing points of the transfer member 18 at the distal end of the catheter 14.

As is clear from FIG. 2 and 3, the inlet chamber 52 is defined on the proximal side by a piston portion 54 of the base portion 30, which can be axially displaced in the inlet chamber 52 and immersed in the inlet chamber 52. To allow sufficient sealing between the free end of the piston portion 54 and the inlet wall chamber 52, an o-ring 56 is provided on the piston portion 54 in the peripheral groove.

The plunger portion 54 also receives the proximal end 58 of the inner catheter 36. As a result, the proximal end 58 of the inner catheter 36 is axially coupled to mate in motion with the plunger portion 54.

The base portion 30 also has a sleeve-like carrier portion 60 that defines a receiving chamber 62. A carrier sleeve 64 is disposed in the receiving chamber 62 in which two axially spaced pivot carriers 66 are provided which pivotally mount the proximal end portion 68 of the rotor shaft 38. The rotor shaft 38 or its end portion 68 extends through the receiving chamber 62. The end portion 68 of the rotor shaft 38 is formed as a rigid shaft which is connected by means of a mating portion 70 to the flexible portion of the rotor shaft 38.

The receiving chamber 62 is also connected to an outlet lumen provided between the inner catheter 36 and the rotor shaft 38. At its proximal end, the base portion 30 has an outlet chamber 74 which connects to outlet 48 and connects to outlet 48 or hose 50. Consequently, the irrigation fluid coming from the bearing points of the transfer member can flow through the outlet lumen receiving chamber 62 and outlet chamber 74 to outlet 48 or hose 50 as indicated by arrow lines 72. As a result, on the one hand, the rotor shaft 38, which rotates during operation in the inner catheter 36, is lubricated, and on the other hand, the pivot carriers 66 can be sufficiently lubricated and cooled.

A rotatable mating portion 78 is provided at the free proximal end 76 of the rotor shaft 38 or at an end portion 68 thereof. The rotatable mating portion 78 comprises a magnetic ring that can be rotated by magnetic mating with a drive side magnetic ring 79 as shown in FIG. 1. An additional magnet can be provided on the rotor shaft 38 or at its end 68 with which it is possible to detect whether the shaft is rotating or not, or at what speed it is rotating, using a suitable sensor in the drive unit.

It is also clear from FIG. 2 and 3 that the base portion 30 has, at its proximal end, a lid 80 which covers the outlet chamber 74 and which also contains the outlet 48.

In order to reliably guide the actuator portion 32 relative to the base portion 30, a cylindrical slide housing 82 is provided at the proximal end of the actuator portion 32. A piston-like slide portion 84 of the base portion 30 is displaceably disposed in the sliding housing 82. The slide portion 84 is formed by lateral surface portions of the support portion 60. By providing the sliding portion 84 and the associated sliding receptacle 82, reliable axial movement of the actuator portion 32 on the base portion 30 can be made possible.

The base part 30 and the executive part 32 can be formed as a whole or in several parts. In the embodiment shown in Fig., The base portion 30 is composed of several individual portions, such as a piston portion 54, a carrier portion 60, together with a carrier sleeve 64 and a cover 80.

Claims (11)

1. Catheter pump (10) having a catheter (14) having a pump head (16) provided at the distal end of the catheter for introduction into the arterial vascular system, the catheter (14) containing an external catheter (34) and an internal catheter (36) located in the outer catheter (34), which has a rotor shaft (38) rotatable in the inner catheter (36) to actuate an expandable transfer member (18) provided on the pump head (16) having an actuator ( 28) provided at the proximal end of the catheter (14), by means of which the rotor shaft (38) can be driven, and has a cage (20) surrounding the transfer element (18), the cage (20) having a distal and proximal couplings (22 , 24) and filaments (26) passing between the sleeves (22, 24), where the proximal sleeve is movable in the axial direction towards the distal sleeve in order to expand the cage (20), characterized in that the executive part (28) contains a part (30) of the base, which is mated in motion with the inner catheter (36) in the axial direction, and an actuating part (32), which can be moved relative to the part (30) of the base in the axial direction and directed to the part (30 ) bases, where the proximal end (40) of the external catheter (34), which has an actuator (32), and the distal end of the external catheter, which has a proximal sleeve, mate in the axial direction so that when the actuator (32) moves away from the (30) of the base, the proximal sleeve moves to the distal sleeve, and the actuating part (32) contains an inlet (44) for the irrigation fluid to be transferred to the bearing points of the transfer element (18) and this part (30) of the base has an outlet ( 48) for the irrigation fluid coming from the bearing points. 2. Catheter pump (10) according to claim 1, characterized in that the executive part (32) comprises an inlet chamber (52) connected to the inlet (44), an inner catheter (36) passing through the inlet chamber (52), and an inlet chamber (52) connected to an inlet lumen provided between the outer catheter (34) and the inner catheter (36) so that irrigation fluid entering through the inlet (44) can flow through the inlet chamber (52) and the inlet lumen to the bearing points of the transfer element (18). 3. Catheter pump (10) according to claim 2, characterized in that the inlet chamber (52) on the proximal side is limited by a portion of the piston (54) of the base part (30), which can be axially displaced in the inlet chamber (52), by the proximal end (58) of the inner catheter (36) is attached to this part of the base and the rotor shaft (38) goes through it. 4. Catheter pump (10) according to claim 1, characterized in that the base part (30) comprises a sleeve-like bearing part (60) having a receiving chamber (62), where bearing points (66) are provided for pivoting the proximal end of the shaft (38, 68) rotor. 5. Catheter pump (10) according to claim 4, characterized in that the carrier sleeve (64) is provided in the receiving chamber (62), where the bearing points are fixed in the form of pivot carriers (66). 6. A catheter pump (10) according to claim 5, characterized in that the pivoting carriers comprise cut-outs through which the irrigation fluid can be guided. 7. Catheter pump (10) according to claim 5 or 6, characterized in that the receiving chamber (62) is connected to the outlet lumen provided between the inner catheter (36) and the rotor shaft (38), so that the irrigation fluid flowing through the outlet lumen, can flow through the receiving chamber (62) to the outlet (48). 8. Catheter pump (10) according to claim 1, characterized in that the base part (30) has, at its proximal end, an outlet chamber (74) connected to an outlet (48) irrigating fluid coming from the receiving chamber (62 ), flows out through the outlet chamber (74) into the outlet (48). 9. Catheter pump (10) according to one of the preceding claims, characterized in that the proximal free end of the rotor shaft (38) has a rotary coupling part (78). 10. Catheter pump (10) according to one of the preceding claims, characterized in that the actuator has, at its proximal end, a cylindrical sliding receptacle (82) for a piston-like sliding part (84) of the base part (30). 11. Catheter pump (10) according to claim 10, characterized in that the sliding part (84) is formed, at least in parts, by the carrier part (60).

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